title: Effect of rimonabant, micronised fenofibrate and their combination on cardiometabolic risk factors in overweight/obese patients: a pilot study.
abstract: OBJECTIVE
  To assess the effect of rimonabant, micronised fenofibrate and their combination on anthropometric and metabolic parameters in overweight/obese patients with dyslipidaemia.
  
  
  METHODS
  All patients (n = 30) received a hypocaloric diet ( approximately 600 kcal/day deficit) and were randomly allocated to receive open-label rimonabant (R) 20 mg/day (n = 10), micronised fenofibrate (F) 200 mg/day (n = 10) or rimonabant 20 mg/day plus fenofibrate 200 mg/day (RF) (n = 10). Anthropometric and metabolic parameters were assessed at baseline and 3 months after treatment initiation.
  
  
  RESULTS
  Compared with baseline similar significant reductions in body weight, body mass index and waist circumference were observed in the R (-6, -5 and -5%, respectively; p < 0.01) and RF group (-5% for all, p < 0.05), while improvements in these parameters were smaller in the F group (-2, -2.5 and -2%, respectively; p < 0.05). Triglycerides were reduced by 18% in the R group (p = NS), by 39% in the F group (p < 0.001) and by 46% in the RF group (p < 0.05). Importantly, combination treatment resulted in a 42% increase in high-density lipoprotein cholesterol (HDL-C) levels (p < 0.05), while HDL-C was not significantly altered in the two monotherapy groups. Subsequently, a more pronounced increase in apolipoprotein A-I (ApoA-I) levels (+25%) was observed in the RF group compared with changes in both monotherapy groups (p < 0.0001 vs R and p < 0.005 vs F group). Low-density lipoprotein cholesterol (LDL-C) levels were not significantly altered in any group. Apolipoprotein B (apoB) levels were reduced in all groups and this reduction was significantly more pronounced in the RF group (p < 0.05 vs baseline as well as p < 0.005 and p < 0.01 for RF vs R and F groups, respectively). ApoB/apoA-I ratio decreased by 3% with R (p = NS), by 18% with F (p < 0.05) and by 40% with RF treatment (p < 0.01). Total cholesterol to HDL-C ratio decreased by 20% with F (p < 0.0001) and by 33% with RF therapy (p < 0.005), while it was not significantly altered in R group.
  
  
  CONCLUSIONS
  The combination of rimonabant and fenofibrate may further improve metabolic parameters in overweight/obese patients with dyslipidaemia compared with each monotherapy. This improvement is particularly pronounced for HDL-C levels.
authors.affiliation: University of Ioannina, Medical School, Department of Internal Medicine, 45110, Ioannina, Greece.
authors.forename: M
authors.initials: M
authors.lastname: Florentin
authors.forename: E N
authors.initials: EN
authors.lastname: Liberopoulos
authors.forename: T D
authors.initials: TD
authors.lastname: Filippatos
authors.forename: C
authors.initials: C
authors.lastname: Kostara
authors.forename: A
authors.initials: A
authors.lastname: Tselepis
authors.forename: D P
authors.initials: DP
authors.lastname: Mikhailidis
authors.forename: M
authors.initials: M
authors.lastname: Elisaf
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002319:Cardiovascular System / Q000187:drug effects* / Q000378:metabolism* / Q000473:pathology; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage / Q000494:pharmacology*; D006321:Heart / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000378:metabolism*; D010865:Pilot Projects; D010880:Piperidines / Q000494:pharmacology*; D011720:Pyrazoles / Q000494:pharmacology*; D000077285:Rimonabant; D012307:Risk Factors; D013997:Time Factors; D055105:Waist Circumference / Q000187:drug effects
chemical_list: D010880:Piperidines; D011720:Pyrazoles; D000077285:Rimonabant; D011345:Fenofibrate